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United States District Court for the Western District of Kentucky UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF KENTUCKY WARREN COUNTY, Civil Action No. ____________ COMPLAINT AND JURY DEMAND Plaintiff, vs TEVA PHARMACEUTICAL INDUSTRIES LTD.; TEVA PHARMACEUTICALS USA, INC. CEPHALON, INC.; JOHNSON & JOHNSON; JANSSEN PHARMACEUTICALS, INC.; ORTHO-MCNEIL-JANSSEN PHARMACEUTICALS, INC. n/k/a JANSSEN PHARMACEUTICALS, INC.; JANSSEN PHARMACEUTICA, INC. n/k/a JANSSEN PHARMACEUTICALS, INC.; ENDO HEALTH SOLUTIONS INC.; ENDO PHARMACEUTICALS, INC.; QUALITEST PHARMACEUTICAL INC.; ABBVIE INC., KNOLL PHARMACEUTICAL COMPANY; ALLERGAN PLC f/k/a ACTAVIS PLC.; ALLERGAN FINANCE LLC f/k/a ACTAVIS INC. f/k/a WATSON PHARMACEUTICALS, INC.; WATSON LABORATORIES, INC.; ACTAVIS LLC; ACTAVIS PHARMA, INC. f/k/a WATSON PHARMA, INC.; MALLINCKRODT PLC; MALLINCKRODT, LLC; MALLINCKRODT BRAND PHARMACEUTICALS; COVIDIEN PLC; SPECGX LLC; CARDINAL HEALTH, INC.; MCKESSON CORPORATION; AMERISOURCEBERGEN CORPORATION; PLAINTIFF’S ORIGINAL COMPLAINT PAGE 1 OF 78 WALGREENS BOOT ALLIANCE, INC. d/b/a WALGREEN CO.; WAL-MART STORES, INC.; CVS HEALTH; RITE AID CORPORATION; THE KROGER COMPANY; AND DOES 1 – 100, INCLUSIVE. Defendants. PLAINTIFF’S ORIGINAL COMPLAINT I. PRELIMINARY STATEMENT 1. Opioid abuse and addiction are a national public health crisis. According to the Centers for Disease Control (“CDC”), over 70,000 Americans died of a drug overdose in 2017, of which 67.8% (47,600) involved opioids. The number of deaths in the United States (hereafter, “U.S.”) and the prevalence of opioids were both worse in 2017 than a year prior.1 2. Unlike the crack cocaine and crystal methamphetamine epidemics that preceded it, this public health crisis was created by the corporate business plan of pharmaceutical manufacturers, including Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd; Cephalon, Inc.; Johnson & Johnson; Janssen Pharmaceuticals, Inc.; Ortho-McNeil-Janssen Pharmaceuticals, Inc. n/k/a Janssen Pharmaceuticals, Inc.; Janssen Pharmaceutica, Inc. n/k/a Janssen Pharmaceuticals, Inc.; Endo Pharmaceuticals Inc.; Endo Health Solutions Inc.; Qualitest Pharmaceuticals Inc.; Abbvie Inc.; Knoll Pharmaceutical Company; Allergan PLC f/k/a Actavis PLC.; Allergan Finance LLC. f/k/a Actavis Inc. f/k/a Watson Pharmaceuticals, Inc.; Watson Laboratories Inc.; Actavis LLC.; Actavis Pharma, Inc. f/k/a Watson Pharma, Inc.; Mallinckrodt PLC; Mallinckrodt Brand Pharmaceutical, Inc.; Mallinckrodt LLC; Covidien PLC and SpecGx 1 Ctr. for Disease Control & Prevention, Drug Overdose Deaths, https://www.cdc.gov/drugoverdose/data/statedeaths.html. According to the CDC, over 63,000 Americans died of a drug overdose in 2016, of which 66.4 percent (42,249) involved opioids. (Ctr. for Disease Control & Prevention, Morbidity and Mortality Weekly Report, March 30, 2016, Overdose Deaths, 2015-2016, https://www.cdc.gov/mmwr/volumes/67/wr/mm6712a1.htm?s_cid=mm6712a1_w.) PLAINTIFF’S ORIGINAL COMPLAINT PAGE 2 OF 78 LLC, who used misrepresentations regarding the risks and benefits of opioids to enable the widespread prescribing of opioids for common, chronic pain conditions like low back pain, arthritis, and headaches.2 3. In addition, these pharmaceutical manufacturers, along with McKesson Corporation, AmerisourceBergen Drug Corporation, Cardinal Health, Inc., Walgreens Boots Alliance d/b/a Walgreen Co., Wal-Mart Stores, Inc., CVS Health, Rite Aid Corporation, and the Kroger Company failed to maintain effective controls, and to investigate, report, and take steps to terminate suspicious orders (such as, orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency). 4. Further, Walgreens Boots Alliance d/b/a Walgreen Co., Wal-Mart Stores, Inc., CVS Health, Rite Aid Corporation, and the Kroger Company held special obligations under the law as registered retail pharmacies. On thousands of occasions, these pharmacies ignored unresolvable red flags and filled prescriptions outside the usual course of practice and for other than a legitimate medical purpose, leading directly to the diversion of millions of pills of highly abused opioid controlled substances. 5. The County brings this action to redress Defendants’ campaign of unfairly, deceptively, and fraudulently marketing, promoting and distributing opioids. 6. Pharmaceutical manufacturers, including Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd; Cephalon, Inc.; Johnson & Johnson; Janssen Pharmaceuticals, Inc.; Ortho-McNeil-Janssen Pharmaceuticals, Inc. n/k/a Janssen Pharmaceuticals, Inc.; Janssen Pharmaceutica, Inc. n/k/a Janssen Pharmaceuticals, Inc.; Endo Pharmaceuticals Inc.; Endo Health Solutions Inc.; Qualitest Pharmaceuticals Inc.; Abbvie Inc.; Knoll Pharmaceutical Company; 2 Consistent with the commonly accepted medical usage, the term “chronic pain” as used herein refers to non-cancer pain lasting three months or longer. PLAINTIFF’S ORIGINAL COMPLAINT PAGE 3 OF 78 Allergan PLC f/k/a Actavis PLC.; Allergan Finance LLC. f/k/a Actavis Inc. f/k/a Watson Pharmaceuticals, Inc.; Watson Laboratories Inc.; Actavis LLC.; Actavis Pharma, Inc. f/k/a Watson Pharma, Inc.; Mallinckrodt PLC; Mallinckrodt Brand Pharmaceutical, Inc.; Mallinckrodt LLC; Covidien PLC.; and SpecGx LLC manufacture, market, and sell prescription opioid pain medications, including the brand-name drugs Actiq, Fentora, Opana/Opana ER, Percodan, Percocet, Zydone, Xartemis XR, Exalgo, Nucynta/Nucynta ER, and Duragesic, and generic drugs such as oxycodone. 7. Pharmaceutical distributors, McKesson Corporation, AmerisourceBergen Drug Corporation, Cardinal Health, Inc., Walgreens Boots Alliance d/b/a Walgreen Co., Wal-Mart Stores, Inc., CVS Health, Rite Aid Corporation, and the Kroger Company distribute opioid medications, including the medications listed above, to pharmacies, pain clinics and other dispensaries across the country and in and around the County. 8. Retail pharmacies, Walgreens Boots Alliance d/b/a Walgreen Co., Wal-Mart Stores, Inc., CVS Health, Rite Aid Corporation, and the Kroger Company are required to review prescriptions issued from licensed and DEA-registered practitioners, such as physicians, and ultimately choose whether or not to fill the issued prescription for the end-user customer. Retail Pharmacies are the final line of defense in preventing the diversion of opioid medications, such as those listed above, for improper use, abuse, or illicit sale, and have consistently failed to fulfill their obligation. While the Pharmacy Defendants have few brick-and-mortar locations within the State, prescriptions filled by these Pharmacy Defendants in other states frequently make their way into Kentucky through various licit and illicit means. 9. Prescription opioids are narcotics. They are derived from and possess properties similar to opium and heroin, and they are regulated as controlled substances. Opioids can create PLAINTIFF’S ORIGINAL COMPLAINT PAGE 4 OF 78 an addictive, euphoric high. At higher doses, they can slow the user’s breathing, causing potentially fatal respiratory depression. Most patients receiving more than a few weeks of opioid therapy will experience severe and often prolonged withdrawal symptoms. When using opioids continuously, patients grow tolerant to their analgesic effects (i.e. to relief of pain)—requiring progressively higher doses and increasing the risks of withdrawal, addiction, and overdose. 10. Because the medical community recognized these dangers, they originally used opioids cautiously and sparingly, typically only for short-term acute pain—where brief use limited the need for escalating doses and the risk of addiction—or for palliative (end-of-life) care. Consequently, the market for prescription opioids was sharply constrained. 11. The above-named pharmaceutical manufacturers began to promote opioids generally, and their own opioids in particular, as safe, effective, and appropriate for even long- term use for routine pain conditions. 12. As part of this strategy, these pharmaceutical manufacturers misrepresented the risk of addiction for pain patients as modest, manageable, and outweighed by the benefits of opioid use. 13. From the day they made the opioids, to the day the medicines were consumed in our communities, including in and around the County, the pharmaceutical manufacturers had control over the information that they chose to spread and emphasize as part of their massive marketing campaign. Consequently, by providing misleading information to doctors about addiction being rare and opioids being safe even in high doses, then pressuring doctors into prescribing more and more of their products by arguing, among other things, that they fail to meet the standard of care if their patients continue to complain of pain, the pharmaceutical PLAINTIFF’S ORIGINAL COMPLAINT PAGE 5 OF 78 manufacturers created a population of addicted patients, including in the County, who sought opioids at never-before-seen rates. 14. On the supply side, the crisis was fueled and sustained by those involved in the supply chain of opioids, including manufacturers, distributors, pharmacies, and individuals (together, “Defendants”), who failed to maintain effective controls over the distribution of prescription opioids and against diversion, and who instead have actively sought to evade such controls and ignore red flags of potential diversion. 15. Defendants have contributed substantially to the opioid crisis by selling and distributing far greater quantities of prescription opioids than they know could be necessary for legitimate medical
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